Fda Approves the First Medical Device for Apple Watch to Warn Wearers of Heart Arrhythmias by Tracki

The US Food and Drug Administration approved an Apple Watch accessory as a medical device for the first time yesterday. The device, called a KardiaBand, inserts into a slot on an Apple Watch and combines its own software and the watch's to constantly monitor heart rate and physical activity. The KardiaBand's artificial intelligence tracks how fast it is normal for the wearer's heart to beat at their various levels of activity in order to create a personalized profile of the wearer's normal heart activity.


Fda Approves the First Medical Device for Apple Watch to Warn Wearers of Heart Arrhythmias by Tracki 1

When that a person's heart rate is abnormal for their activity level, it prompts the user to take an EKG, a far more accurate measure for identifying arrhythmias. The KardiaBand EKG device can be purchased for $199, and works with a $99 annual subscription to software from KardiaBand's maker, AlivCor. The Apple Watch, Fitbit and Jawbone UP products all measure heart rates, but studies have shown that their metrics are fairly inaccurate.

In January of last year, Fitbit was even sued based on its tracker's flaws. The FDA, in an effort to keep up with emerging wearable technologies, created a fast track specific to the prolific sector. Apple, Samsung and Fitbit were among the nine companies accepted to participate in the pilot program.

But Apple avoided the time, money and effort of the FDA-approval process. KardiaBand's add-on technology gives users the option to convert an Apple Watch into a more accurate heart rate monitor. KardiaBand monitors heart rate through an electrocardiogram (EKG), the same diagnostic technology used by cardiologists and emergency rooms.

EKGs pick up on tiny electrical pulses associated with the heartbeat to measure its pace and rhythm. There are plenty of personal, wearable EKGs on the consumer market. These tend to be more expensive and have shorter battery lives because they monitor heart rates continuously, and they do not have the consumer bases and brand cache of a brand like Apple.


Fda Approves the First Medical Device for Apple Watch to Warn Wearers of Heart Arrhythmias by Tracki 2

Constant heart rate monitoring is also not particularly necessary to most users, and a source of undue stress for some. Instead, Smart Rhythm - the new device's software component, embedded in the Kardia Apple Watch app - analyzes information gathered from the watch's built-in sensors, only taking an EKG when the user presses a button on the band. The software logs data about the particular user's typical heart rate and physical activity.

It learns what is 'normal' for the wearer to create an individualized baseline. This personalized data helps the watch and accessory to more accurately detect trouble. The Apple Watch measures heart rate through the color of light reflected by blood pumped into the wrist, a technology called photoplethysmography (PPG) - the same process used by fingertip pulse monitors.

The watch monitor is less accurate than Kardiaband's EKG, but, combined with activity data gathered by the watch's accelerometer, it's enough to tell the embedded KardiaBand if your heart rate is abnormal for you. If it is, the device notifies the wearer that they should touch the band to take an instant EKG. The read out can notify the user if they are having the most common types of heart arrhythmias: anatrial fibrillation, which can cause a stroke.

'EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke,' said University of Southern California Los Angeles cardiologist Dr Ronald Karlsberg in AliveCor's statement. He called the KardiaBand 'a giant leap in personalized health care. 'With an EKG device on the wrist, [atrial fibrillation] can be detected wherever the patient is, 24 hours a day,' he added.

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How Helpful Are the Apple Watch Series 4s ECG Readings?
How Helpful Are the Apple Watch Series 4s ECG Readings?
The Apple Watch Series 4 is nabbing headlines with its electrocardiogram (ECG) and heart health capabilities, but will anybody use these features correctly?By Victoria SongLast week, Apple unveiled the Apple Watch Series 4 the fourth iteration of its popular smartwatch. Capable of detecting falls, identifying abnormal heart rhythms, and taking electrocardiograms, Series 4 is the tech giants most overt foray into wearable medical technology.Giving the Series 4 some cred is the fact its atrial fibrillation (AFib) and ECG tech received clearance from the Food and Drug Administration. It also helped that Apple had Ivor Benjamin, president of the American Heart Association, onstage at its press event to speak about the potential life-saving applications of having an ECG machine on your wrist at all times.This is all very impressive from a hardware standpoint, but the question is: How relevant are these features for relatively healthy people under 60?AFib affects somewhere between 2.7 and 6.1 million Americans according to the Centers for Disease Control. But its also a condition that primarily affects older individuals. According to a JAMA study, 70 percent of people with AFib are between 65 and 85 years old. And unless youre of a certain age, chances are you havent had an ECG as part of your yearly physical. Unless you have chest pain, a heart condition, or are getting surgery, doctors have no reason to administer ECGs to an otherwise healthy adult.In a letter from the FDA, the agency notes that Apples ECG app is intended for over-the-counter use only, and definitely isnt meant as a diagnostic tool. But hypochondria and obsessive self-quantification are very real. Ive no doubt some overeager health nuts might overdo it and turn what was meant as a preventive tool into a source of needless anxiety.Furthermore, data without context is less than helpful. We dont know much about the ECG app thus far, other than it measures your heart rhythm, stores PDFs of your readings on Apple Health, and wont be available on the Series 4 until later this year. The average person probably has no idea what a normal ECG looks like, and simply handing over your iPhone with a dozen charts to your doctor might result in more confusion than insight.The idea of being able to continuously collect data on ourselves and present them as evidence to health care professionals is a compelling one. But after more than a year of testing wearables, Ive mostly found my physicians dont know what to do with spreadsheets and graphs of data exported from apps. The numbers are divorced from vital context about my lifestyle, family history, and physical condition at the time the readings were taken. And honestly, I dont know what a lot of my data means either. It has been helpful for me to understand what my baseline is, but at the end of the day, Im no more knowledgeable about medicine than what I can search on WebMD. Of course, if you are over 60, have a high risk of heart disease, or are diagnosed with AFib, the Series 4 has value provided you consult with your doctor. Even so, its important to keep in mind the basics when it comes to gathering data. One healthy reading wouldnt put you in the clear, but a bad reading wouldnt mean youre on the road to death either. Really, the watchs most useful purpose is to help at-risk consumers stay mindful of their heart health consistently over time. (And to be frank, better battery life would have helped with that.) Prevention is no small thing, but itll be interesting to see if those most at risk are willing to shell out more than $400 for a smartwatch specifically for this reason. As for the rest of us? I suspect well use the Series 4s heart health features once or twice before forgetting about it completely.Read more: Hands On With the Apple Watch Series 4Originally published at
2021 05 24
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The Apple Watch ECG Function: Some Thoughts
The Apple Watch ECG Function: Some Thoughts
Yesterday, I upgraded my iPhone to iOS 12.2 and immediately after that, my Apple Watch to watchOS 5.2, the main novelty of which for Europe is an electrocardiogram and frequency alerts function, which previously lacked regulatory approval. Finally, six months after the FDA approved it as a Class 2 Medical Device, the two features are already CE approved for use in the European Economic Area.Speaking as somebody who has suffered atrial fibrillation episodes on several occasions, and who underwent a cryoablation of my pulmonary veins in December, this is a subject of greater interest to me than most people. Since my post-op, which was quite uncomfortable, I am a user of Kardia, another FDA-approved device, to control my heart rate, which I combine with another Hungarian-made invention, Wiwe, which provides me with more analytical information, although its not the first choice for the cardiologists I have spoken to. After several months controlling my heart rate 24/7 with the Kardias SmartRhythm app for Apple Watch, which carries out a permanent algorithmic analysis and warns when it detects unusual measurements, I think I already know my heart and its symptoms well enough to allow me to evaluate the electrocardiogram function of the Apple Watch. Over the last three months, as well as monitoring my heart rate, I have taken a couple of electrocardiograms every day, as well as frequently measuring my blood pressure. Apple Watchs electrocardiogram feature will now be able to help me with the monitoring associated with final stages of my treatment with anticoagulants and antiarrhythmics after the end of my blanking period of my operation, which happened last Wednesday. 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My initial impression, without talking to a cardiologist, is that it falls between the other two apps I know: its not as dirty as Wiwe or as clean as Kardia, with a result that might qualify as sinus rhythm (uniform pattern), but that could also be labeled as atrial fibrillation, or, in some cases as inconclusive (if your heart rate is lower than 50, greater than 120, or if the measurement has not been performed under the right conditions (low battery levels, etc.)The application is compatible with Kardias SmartRhythm monitor Kardia, which is progress, because the Apple Watchs other functions, such as exercise, arent, which forces you to choose, when you exercise, between using Apples application, oriented to providing information about the exercise, or Kardia, which focuses on your heart. In fact, the Apple Watch mistakenly identifies Kardia as an exercise monitor, providing constant monitoring which is of no use at all. Monitoring the heart rate is valuable, but obviously not enough to properly assess heart health. That said, the continuous monitoring provided by the Apple Watch or other devices has advantages, simply in statistical terms, over the occasional evaluation provided by a specialized device that only a hospital can provide. The possibilities for processing all this real time data are enormously interesting and should not be minimized, and in fact, a Stanford University study with 400,000 Apple Watch users offers conclusive results. The ECG data captured by the Apple Watch are stored in the Health application of the iPhone, where they can be consulted or shown to a doctor at any time, along with other relevant data such as weight, blood pressure, movement, exercise, sleep, etc.Over the next few days, given that I must continue monitoring my heart rate following the after the end of my treatment, I may update this entry with more impressions.(En espaol, aqu)
2021 05 24
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